Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
apremilast
Amgen Europe BV
L04AA32
apremilast
Immunosuppressants
Arthritis, Psoriatic; Psoriasis
Psoriatic arthritisOtezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.PsoriasisOtezla is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).
Revision: 21
Authorised
2015-01-15
33 B. PACKAGE LEAFLET 34 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OTEZLA 10 MG FILM-COATED TABLETS OTEZLA 20 MG FILM-COATED TABLETS OTEZLA 30 MG FILM-COATED TABLETS apremilast READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Otezla is and what it is used for 2. What you need to know before you take Otezla 3. How to take Otezla 4. Possible side effects 5. How to store Otezla 6. Contents of the pack and other information 1. WHAT OTEZLA IS AND WHAT IT IS USED FOR WHAT OTEZLA IS Otezla contains the active substance ‘apremilast’. This belongs to a group of medicines called phosphodiesterase 4 inhibitors, which help to reduce inflammation. WHAT OTEZLA IS USED FOR Otezla is used to treat adults with the following conditions: • ACTIVE PSORIATIC ARTHRITIS - if you cannot use another type of medicine called ‘Disease-Modifying Antirheumatic Drugs’ (DMARDs) or when you have tried one of these medicines and it did not work. • MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS - if you cannot use one of the following treatments or when you have tried one of these treatments and it did not work: - phototherapy - a treatment where certain areas of skin are exposed to ultraviolet light - systemic therapy - a treatment that affects the entire body rather than just one local area, such as ‘ciclosporin’, ‘methotrexate’ or ‘psoralen ’. • BEHÇET’S DISEASE (BD) - to treat the mouth ulcers which is a common problem for people with this illness. WHAT PSORIATIC ARTHRITIS IS Psoriati Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Otezla 10 mg film-coated tablets Otezla 20 mg film-coated tablets Otezla 30 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Otezla 10 mg film-coated tablets Each film-coated tablet contains 10 mg of apremilast. _Excipient(s) with known effect _ Each film-coated tablet contains 57 mg of lactose (as lactose monohydrate). Otezla 20 mg film-coated tablets Each film-coated tablet contains 20 mg of apremilast. _ _ _Excipient(s) with known effect _ Each film-coated tablet contains 114 mg of lactose (as lactose monohydrate). Otezla 30 mg film-coated tablets Each film-coated tablet contains 30 mg of apremilast. _ _ _Excipient(s) with known effect _ Each film-coated tablet contains 171 mg of lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Otezla 10 mg film-coated tablets Pink, diamond shaped 10 mg film-coated tablet of 8 mm length with “APR” engraved on one side and “10” on the opposite side. Otezla 20 mg film-coated tablets Brown, diamond shaped 20 mg film-coated tablet of 10 mm length with “APR” engraved on one side and “20” on the opposite side. Otezla 30 mg film-coated tablets Beige, diamond shaped 30 mg film-coated tablet of 12 mm length with “APR” engraved on one side and “30” on the opposite side. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Psoriatic arthritis Otezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy (see section 5.1). Psoriasis Otezla is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and u Przeczytaj cały dokument